FDA expands indication for pembrolizumab in NSCLC

 

The Food and Drug Administration has approved pembrolizumab for the treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors express PD-L1 as determined by an FDA-approved test. This is the first approval of a checkpoint inhibitor for first-line treatment of the disease.

Pembrolizumab (Keytruda) is now approved to treat patients with metastatic NSCLC whose tumors have high PD-L1 expression (Tumor Proportion Score [TPS] greater than or equal to 50%), with no EGFR or ALK genomic tumor aberrations, and no prior systemic chemotherapy treatment for metastatic NSCLC, the FDA said in a written statement.

The approval also expands the indication in second-line treatment to include all NSCLC patients with PD-L1–expressing tumors (TPS greater than or equal to 1%). Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving pembrolizumab.

The FDA based its approval on improvement in overall survival in two trials comparing treatment with pembrolizumab to treatment from chemotherapy. In one trial of 305 patients who had no prior treatment for metastatic NSCLC and TPS greater than or equal to 50%, those who received pembrolizumab (200 mg every 3 weeks) had a statistically significant improvement in overall survival, compared with patients randomized to receive chemotherapy (hazard ratio, 0.60; 95% confidence interval, 0.41-0.89; P less than .005). There was also significant improvement in progression-free survival for those receiving the checkpoint inhibitor (HR, 0.50; 95% CI, 0.37-0.68; P less than .001).

In the second trial, a three-arm trial of 1,033 patients who were previously treated for metastatic NSCLC with a TPS greater than or equal to 1%, those randomized to pembrolizumab 2 mg/kg every 3 weeks (HR, 0.71; 95% CI, 0.58-0.88; P less than .001) or pembrolizumab 10 mg/kg every 3 weeks (HR, 0.61; 95% CI, 0.49-0.75; P less than .001) had an improved overall survival, compared with patients receiving docetaxel. The median survival was 10.4 months in the pembrolizumab 2 mg/kg arm, 12.7 months in the pembrolizumab 10 mg/kg arm, and 8.5 months in the docetaxel arm.

The most common side effects of treatment with pembrolizumab included decreased appetite, fatigue, nausea, dyspnea, cough, and constipation. Rare but serious adverse events included immune-mediated pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis, the FDA said.

The recommended dose and schedule of pembrolizumab for NSCLC is 200 mg intravenously every 3 weeks. Full prescribing information is available here.

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On Twitter @nikolaideslaura

 

The Food and Drug Administration has approved pembrolizumab for the treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors express PD-L1 as determined by an FDA-approved test. This is the first approval of a checkpoint inhibitor for first-line treatment of the disease.

Pembrolizumab (Keytruda) is now approved to treat patients with metastatic NSCLC whose tumors have high PD-L1 expression (Tumor Proportion Score [TPS] greater than or equal to 50%), with no EGFR or ALK genomic tumor aberrations, and no prior systemic chemotherapy treatment for metastatic NSCLC, the FDA said in a written statement.

The approval also expands the indication in second-line treatment to include all NSCLC patients with PD-L1–expressing tumors (TPS greater than or equal to 1%). Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving pembrolizumab.

The FDA based its approval on improvement in overall survival in two trials comparing treatment with pembrolizumab to treatment from chemotherapy. In one trial of 305 patients who had no prior treatment for metastatic NSCLC and TPS greater than or equal to 50%, those who received pembrolizumab (200 mg every 3 weeks) had a statistically significant improvement in overall survival, compared with patients randomized to receive chemotherapy (hazard ratio, 0.60; 95% confidence interval, 0.41-0.89; P less than .005). There was also significant improvement in progression-free survival for those receiving the checkpoint inhibitor (HR, 0.50; 95% CI, 0.37-0.68; P less than .001).

In the second trial, a three-arm trial of 1,033 patients who were previously treated for metastatic NSCLC with a TPS greater than or equal to 1%, those randomized to pembrolizumab 2 mg/kg every 3 weeks (HR, 0.71; 95% CI, 0.58-0.88; P less than .001) or pembrolizumab 10 mg/kg every 3 weeks (HR, 0.61; 95% CI, 0.49-0.75; P less than .001) had an improved overall survival, compared with patients receiving docetaxel. The median survival was 10.4 months in the pembrolizumab 2 mg/kg arm, 12.7 months in the pembrolizumab 10 mg/kg arm, and 8.5 months in the docetaxel arm.

The most common side effects of treatment with pembrolizumab included decreased appetite, fatigue, nausea, dyspnea, cough, and constipation. Rare but serious adverse events included immune-mediated pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis, the FDA said.

The recommended dose and schedule of pembrolizumab for NSCLC is 200 mg intravenously every 3 weeks. Full prescribing information is available here.

[email protected]

On Twitter @nikolaideslaura

 

The Food and Drug Administration has approved pembrolizumab for the treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors express PD-L1 as determined by an FDA-approved test. This is the first approval of a checkpoint inhibitor for first-line treatment of the disease.

Pembrolizumab (Keytruda) is now approved to treat patients with metastatic NSCLC whose tumors have high PD-L1 expression (Tumor Proportion Score [TPS] greater than or equal to 50%), with no EGFR or ALK genomic tumor aberrations, and no prior systemic chemotherapy treatment for metastatic NSCLC, the FDA said in a written statement.

The approval also expands the indication in second-line treatment to include all NSCLC patients with PD-L1–expressing tumors (TPS greater than or equal to 1%). Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving pembrolizumab.

The FDA based its approval on improvement in overall survival in two trials comparing treatment with pembrolizumab to treatment from chemotherapy. In one trial of 305 patients who had no prior treatment for metastatic NSCLC and TPS greater than or equal to 50%, those who received pembrolizumab (200 mg every 3 weeks) had a statistically significant improvement in overall survival, compared with patients randomized to receive chemotherapy (hazard ratio, 0.60; 95% confidence interval, 0.41-0.89; P less than .005). There was also significant improvement in progression-free survival for those receiving the checkpoint inhibitor (HR, 0.50; 95% CI, 0.37-0.68; P less than .001).

In the second trial, a three-arm trial of 1,033 patients who were previously treated for metastatic NSCLC with a TPS greater than or equal to 1%, those randomized to pembrolizumab 2 mg/kg every 3 weeks (HR, 0.71; 95% CI, 0.58-0.88; P less than .001) or pembrolizumab 10 mg/kg every 3 weeks (HR, 0.61; 95% CI, 0.49-0.75; P less than .001) had an improved overall survival, compared with patients receiving docetaxel. The median survival was 10.4 months in the pembrolizumab 2 mg/kg arm, 12.7 months in the pembrolizumab 10 mg/kg arm, and 8.5 months in the docetaxel arm.

The most common side effects of treatment with pembrolizumab included decreased appetite, fatigue, nausea, dyspnea, cough, and constipation. Rare but serious adverse events included immune-mediated pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis, the FDA said.

The recommended dose and schedule of pembrolizumab for NSCLC is 200 mg intravenously every 3 weeks. Full prescribing information is available here.

[email protected]

On Twitter @nikolaideslaura